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已发表论文
在标准化试验中更准确地评估个性化中医干预：引入 TRIPLE-TCM 试验框架以调和方法论范式
Authors Zhao FY , Yue LP, Xu P, Conduit R , Zhang WJ, Lee YX , Fu QQ , Chow CM
Received 11 August 2025
Accepted for publication 25 October 2025
Published 4 November 2025 Volume 2025:21 Pages 1521—1534
DOI https://doi.org/10.2147/TCRM.S557457
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Professor Garry Walsh
Fei-Yi Zhao,1– 4,* Li-Ping Yue,1,* Peijie Xu,5,* Russell Conduit,2,* Wen-Jing Zhang,4 Yuan Xin Lee,4 Qiang-Qiang Fu,6 Chin Moi Chow3
1Department of Nursing, School of International Medical Technology, Shanghai Sanda University, Shanghai, 201209, People’s Republic of China; 2School of Health and Biomedical Sciences, RMIT University, Bundoora, VIC, 3083, Australia; 3Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Camperdown, NSW, 2050, Australia; 4Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, People’s Republic of China; 5School of Computing Technologies, RMIT University, Melbourne, VIC, 3000, Australia; 6Yangpu Hospital, School of Medicine, Tongji University, Shanghai, 200090, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Qiang-Qiang Fu, Yangpu Hospital, School of Medicine, Tongji University, Shanghai, 200090, People’s Republic of China, Tel + 86 021-6569 0520, Fax + 86 021-6569 6249, Email qiangqiang.fu@tongji.edu.cn Fei-Yi Zhao, Department of Nursing, School of International Medical Technology, Shanghai Sanda University, Shanghai, 201209, People’s Republic of China, Tel +86 5021-0894, Fax +86 5021-0895, Email fyzhao@sandau.edu.cn; fei-yi.zhao@rmit.edu.au
Abstract: Traditional Chinese Medicine (TCM) prioritizes highly individualized diagnosis and treatment, a principle that inherently conflicts with the standardized protocols of explanatory randomized controlled trials (RCTs). While pragmatic RCTs have been proposed to better reflect real-world TCM practice, their reliance on unblinded designs raises concerns about placebo effects and potential confounding biases, particularly for interventions like acupuncture. These methodological tensions highlight the need for innovative trial designs that can preserve TCM’s personalized ethos while meeting the rigorous standards of evidence-based research. In response, we propose the Trans-paradigm Randomized-Individualized-Preference-Linked Efficacy/Effectiveness Evaluation for TCM (TRIPLE-TCM) framework—a hybrid trial design integrating explanatory RCTs, pragmatic RCTs, and partially randomized patient preference trials. TRIPLE-TCM employs a five-step procedure: (1) TCM pattern-guided recruitment to ensure diagnostic homogeneity; (2) hybrid randomization accommodating patient preferences; (3) semi-standardized interventions combining fixed core prescriptions with individualized adjustments; (4) a clinician-patient co-assessment model incorporating TCM-specific outcomes and validated biomarkers; and (5) cost-utility analyses to inform policy. This framework aims to balance internal and external validity while maintaining fidelity to TCM theory and clinical practice, providing a methodological bridge for TCM’s broader acceptance. Further studies should validate its feasibility, reproducibility, and cross-cultural generalizability across diverse disease contexts and healthcare settings, advancing evidence-based integration of acupuncture and Chinese herbal medicine into global healthcare systems.
Keywords: explanatory RCTs, pragmatic RCTs, randomized controlled trials, evidence-based medicine, TCM standardization, efficacy and effectiveness
1Department of Nursing, School of International Medical Technology, Shanghai Sanda University, Shanghai, 201209, People’s Republic of China; 2School of Health and Biomedical Sciences, RMIT University, Bundoora, VIC, 3083, Australia; 3Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Camperdown, NSW, 2050, Australia; 4Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, People’s Republic of China; 5School of Computing Technologies, RMIT University, Melbourne, VIC, 3000, Australia; 6Yangpu Hospital, School of Medicine, Tongji University, Shanghai, 200090, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Qiang-Qiang Fu, Yangpu Hospital, School of Medicine, Tongji University, Shanghai, 200090, People’s Republic of China, Tel + 86 021-6569 0520, Fax + 86 021-6569 6249, Email qiangqiang.fu@tongji.edu.cn Fei-Yi Zhao, Department of Nursing, School of International Medical Technology, Shanghai Sanda University, Shanghai, 201209, People’s Republic of China, Tel +86 5021-0894, Fax +86 5021-0895, Email fyzhao@sandau.edu.cn; fei-yi.zhao@rmit.edu.au
Abstract: Traditional Chinese Medicine (TCM) prioritizes highly individualized diagnosis and treatment, a principle that inherently conflicts with the standardized protocols of explanatory randomized controlled trials (RCTs). While pragmatic RCTs have been proposed to better reflect real-world TCM practice, their reliance on unblinded designs raises concerns about placebo effects and potential confounding biases, particularly for interventions like acupuncture. These methodological tensions highlight the need for innovative trial designs that can preserve TCM’s personalized ethos while meeting the rigorous standards of evidence-based research. In response, we propose the Trans-paradigm Randomized-Individualized-Preference-Linked Efficacy/Effectiveness Evaluation for TCM (TRIPLE-TCM) framework—a hybrid trial design integrating explanatory RCTs, pragmatic RCTs, and partially randomized patient preference trials. TRIPLE-TCM employs a five-step procedure: (1) TCM pattern-guided recruitment to ensure diagnostic homogeneity; (2) hybrid randomization accommodating patient preferences; (3) semi-standardized interventions combining fixed core prescriptions with individualized adjustments; (4) a clinician-patient co-assessment model incorporating TCM-specific outcomes and validated biomarkers; and (5) cost-utility analyses to inform policy. This framework aims to balance internal and external validity while maintaining fidelity to TCM theory and clinical practice, providing a methodological bridge for TCM’s broader acceptance. Further studies should validate its feasibility, reproducibility, and cross-cultural generalizability across diverse disease contexts and healthcare settings, advancing evidence-based integration of acupuncture and Chinese herbal medicine into global healthcare systems.
Keywords: explanatory RCTs, pragmatic RCTs, randomized controlled trials, evidence-based medicine, TCM standardization, efficacy and effectiveness